FDA Inspection
Michael Racke MDMichael Racke MD – FDA Inspection, Jun 15, 2018
Record Details
This FDA Inspection record concerns Michael Racke MD, with an inspection on June 15, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 8343a193-36f0-47b6-8c07-130e90073df8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1055787
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.66Unanticipated problems
- 21 CFR 50.27(a)Consent form not approved/signed/dated
- 21 CFR 312.62(a)Accountability records
- 21 CFR 312.62(a)Unused drug disposition (investigator)
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